- The Karyopharm Therapeutics Inc (NASDAQ: KPTI) stock is trending today. This is why.
The Karyopharm Therapeutics Inc (NASDAQ: KPTI) stock is trending today. And the company stock price fell by over 25% pre-market today. Investors are responding negatively to an announcement from the company.
Karyopharm Therapeutics provided an update on its discussions with the U.S. Food and Drug Administration (FDA) regarding its previously planned supplemental New Drug Application (sNDA) submission based on the data from the Phase 3 SIENDO study evaluating selinexor as a front-line maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer.
During a productive meeting with the FDA, the company had received feedback that the current SIENDO study top-line results are unlikely to support an sNDA approval. And Karyopharm and the FDA participants had differing views on the study significance and overall clinical benefit for the whole population and discussed that further exploration of patients with advanced or recurrent endometrial cancer with p53 wild-type is warranted.
The company is going to continue to collect and analyze the SIENDO study data and work with the FDA to explore all regulatory pathways for patients with p53 wild-type. And considering the FDA’s feedback, the company intends to initiate a new placebo-controlled, randomized clinical study of selinexor in patients with p53 wild-type endometrial cancer and believes top-line data will be available in the first half of 2024.
Karyopharm plans to rapidly initiate this study of selinexor in patients with p53 wild-type this year, working with the FDA as well as established networks and partners, including the European Network of Gynaecological Oncological Trial groups (ENGOT) and the Gynecologic Oncology Group Foundation, Inc. (GOG-F).
The Phase 3 SIENDO study has been selected for presentation at the upcoming European Society of Medical Oncology’s Virtual Plenary taking place on Thursday, March 17, 2022, and at the Society for Gynecologic Oncology 2022 Annual Meeting on Women’s Cancer taking place March 18-21, 2022 in Phoenix, Arizona.
“We strongly believe in selinexor’s potential in patients with p53 wild-type and are excited to further evaluate it in this patient population to better understand its potential to address the unmet need in women with endometrial cancer. Given the significant need for new therapeutic options, we have a tremendous sense of urgency to design and enroll a new trial as quickly as possible and believe we are well-positioned to do so working with our existing SIENDO clinical trial sites.”
— Sharon Shacham, Chief Scientific Officer of Karyopharm
“The majority of endometrial cancers are diagnosed at an early stage and are typically curable with surgery, however, women with advanced and recurrent endometrial cancer have very limited therapeutic options following front-line treatments and prognosis is typically poor. Selinexor has the potential to transform the way advanced or recurrent endometrial cancer is treated in patients with p53 wild-type and I look forward to learning more from a new study.”
— Professor Ignace Vergote, principal investigator and gynecologist oncologist, ENGOT and the Belgium and Luxembourg Gynaecological Oncology Group (BGOG), University of Leuven, Leuven Cancer Institute, Leuven, Belgium
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